Growing Oligonucleotide-based Drugs Pipeline Escalates Manufacturing Demand

Author: Srishti Khurana

As therapeutic agents, oligonucleotides are known to be associated with several unique features, such as high selectivity and potency (similar to biologics), and differentiated pharmacology, which further augment their drug-like properties. At present, eight oligonucleotide-based drugs are available in the market, namely (in reverse chronological order of year of approval) GIVLAARI™ (2019), ONPATTRO® (2018), TEGSEDI™ (2018), SPINRAZA® (2016), EXONDYS 51® (2016), DEFITELIO® (2016), KYNAMRO™ (2013), and MACUGEN® (2004). As the market for such therapeutic interventions continues to evolve, it is likely to induce a steadily growing demand for oligonucleotides.

Recent Clinical Activity in the Oligonucleotide Domain

More than 200 unique oligonucleotide-based product candidates are currently being evaluated in various preclinical / clinical phases of development. In fact, we came across more than 270 registered clinical trials focused on oligonucleotides, till 2019; it is worth noting that the maximum (34) number of trials were registered in 2019.

Further, these trials recruited more than 47,400 patients, across the globe. It is important to highlight that most of the trials being conducted within this domain are / were evaluating antisense oligonucleotides (110), followed by those involving the use of siRNAs (101).

Oligonucleotides – clinical research landscape

Current Annual Demand for Oligonucleotide Manufacturing

By 2030, it is expected that siRNAs are likely to capture the highest share of the overall clinical demand for oligo nucleotides. In addition, in 2030, majority of the clinical demand is likely to be generated by oligonucleotides being investigated for the treatment of oncological disorders, followed by those intended for ophthalmic disorders and metabolic disorders. Further, majority of the current as well as future demand for oligonucleotides is likely to generated in developed regions, such as North America and Europe.

Oligonucleotides – manufacturing demand analysis

Recent Activity in the Oligonucleotide Domain

The current oligonucleotide manufacturing landscape comprises of more than 80 players that claim to have the capability to manufacture oligonucleotides, at varying scales, for various pharmacological interventions. Further, in order to keep pace with the growing demand for oligonucleotides, these service providers are increasingly investing in or entering into collaborations to expand their existing capabilities. Majority of the partnership instances were reported to be manufacturing and supply agreements, followed by mergers / acquisitions.

Oligonucleotides – recent expansions

To know more about the evolving oligonucleotide manufacturing market, check out the report Under –

Oligonucleotide Synthesis, Modification and Purification Services Market: Focus on Research, Diagnostic and Therapeutic Applications, 2020-2030

The "Oligonucleotide Synthesis, Modification and Purification Services Market: Focus on Research, Diagnostic and Therapeutic Applications, 2020-2030" report features a detailed study of the current scenario and future potential of the custom synthesis, modification and purification services market for oligonucleotides, which are intended for research, diagnostic, and therapeutic applications. The study includes in-depth analyses, highlighting the capabilities of service providers engaged in this domain.

Key Questions Answered

  • Who are the leading manufacturers of oligonucleotides for use in research, diagnostic and therapeutic applications?

  • What are the preferred custom synthesis, modification and purification methods used for oligonucleotides?

  • What are the key challenges faced by oligonucleotide manufacturers?

  • What kind of partnership models are commonly adopted by industry stakeholders?

  • What are the recent expansion initiatives undertaken by service providers within this domain?

  • What is the annual clinical and commercial demand for oligonucleotides?

  • What is the current, installed manufacturing capacity for oligonucleotides?

  • What percentage of oligonucleotide manufacturing operations are outsourced to service providers?

  • What are the opportunities in emerging markets for oligonucleotide manufacturing?

  • How is the current and future market opportunity likely to be distributed across key market segments?

  • What are the anticipated future trends related to oligonucleotide manufacturing?